If your organization manufactures, designs, distributes, or services medical devices, you need to prepare it for getting the ISO 13485 certification. It is the ultimate benchmark of quality performance for medical device companies, no matter what the size or types of products/services it offers. The ISO 13485 standard was developed by ISO to provide guidelines to the organizations in the medical device field for forming their QMS (Quality Management System). It would hence help them to address quality issues and meet the requirements of customers. ISO 13485, being an internationally recognized medical device standard, also enables the companies to address the industry regulations and requirements provided by law and other medical device authorities.
To put it simply, the ISO 13485 standard helps a medical device company to develop a compliant QMS to take care of their quality aspects and maintain the high quality and safety of medical devices. More importantly, the QMS also helps organizations consistently ensure that their devices or processes abide by the regulatory requirements. To know exactly how a QMS should be developed according to this medical device specific standard, you need to understand its requirements first. This blog briefly explains them.
Medical Device QMS Requirements as Specified by the ISO 13485 Certification
General QMS Requirements
The first set of requirements of ISO 13485 is based on the general QMS standard, ISO 9001. It specifies the need to document the QMS for ensuring consistency and effectiveness of the quality processes. It then includes determining procedures, activities, or controls that should be carried out by your organization to ensure the safety, quality, and compliance of the devices. The requirements also state that it is necessary to have a sequence and interaction of appropriate processes required under the QMS. Also, the organization should make the necessary information available to the employees for supporting or initiating those processes. The procedures for monitoring, analyzing, and measuring the quality performance are also included in the QMS requirements. Lastly, the requirements also include the need to maintain records or evidence for demonstrating conformance to the regulatory requirements.
Documentation Requirements
Detailed documentation is a vital part of the standard, and it helps organizations to prove their compliance with the standard to the external auditors. To meet compliance with the ISO 13485 standard, your medical device organization must meet the following documentation requirements.
Quality policy and a defined set of quality objectives
• A properly structured quality manual
• Documented procedures as specified by the ISO 13485 standard
• Records of planning, implementation and execution of the QMS processes
• Documentation of information as required by applicable medical device regulations and legislative regulations
Quality Manual Requirements
In the case of medical device organizations, the quality manual must be created following the specific manual requirements mentioned by the QMS. The manual requirements include the scope of QMS, established procedures for quality management, and description of how the processes should interact or take place to achieve the proposed objectives i.e., high-quality and safe devices.
Medical File Requirements
The ISO 13485 standard also requires the medical device organizations to create and retain appropriate files required for demonstrating the conformity of medical devices to the standard as well as important regulatory requirements. The content of the files typically includes basic details and descriptions of the devices, purpose, packaging instructions, labeling requirements, instructions for use, procedures for appropriate use and storage, and any procedures for maintaining it.
Final Words
If you want your medical device business to stand apart from the rest of companies, the ISO 13485 certification is the best way to achieve that. Thus, make yourself familiar with these ISO 13485 requirements as complying with them is necessary to make sure that your QMS is competent. If these requirements seem challenging to you, it is recommended to consult with a dedicated agency that assists and guides businesses in the ISO certifications. They would help you initiate and implement a QMS adhering to all the requirements of the standard and make your business worthy in the competitive medical device industry.
